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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K203808
Device Name Multi-unit Abutment, Multi-unit Angled Abutment
Applicant
Megagen Implant Co., Ltd.
45, Secheon-Ro, 7-Gil
Daegu,  KR 42921
Applicant Contact You Jung Kim
Correspondent
Daegyeong Regulatory Affairs Institute
32, Innovalley-Ro
Daegu,  KR 41065
Correspondent Contact You Jung Kim
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/28/2020
Decision Date 10/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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